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      Opportunities for Patient Benefit Using Approved Therapies: The Critical, First-in-Human Trial

      Published
      proceedings-article
      1
      ScienceOpen
      RExPO22
      2-3 September, 2022
      Clinical trial, Drug repurposing, Off-label pharmaceuticals, FDA
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            Abstract

            Until recently, the process of bringing repurposed drugs to broadly reach patients with unsolved medical needs was well-known to healthcare stakeholders, but not often to the public. The COVID-19 pandemic brought repurposing into the public eye more than ever. But the ease of patients receiving repurposed drugs differs by country. In the US, doctors can prescribe any FDA-approved drug for their patients, regardless of whether that drug has been approved to treat the patient’s condition, called off-label use. Approximately 20% of all prescriptions written in the US are written ‘off-label”. Randomized controlled trials can provide data necessary for physicians (and their patients) to consider off-label drug use as well as for regulatory agencies to approve a drug for a new indication, when appropriate. This session will discuss the critical Phase I or IIA, first-in-human, proof-of-concept or pivotal clinical trial that, when successful, can catalyze the funding required for a follow-on Phase IIB or III trial required for broad off-label use and/or for regulatory approvals.

            Content

            Author and article information

            Conference
            ScienceOpen
            17 August 2022
            Affiliations
            [1 ] Cures Within Reach, Chicago, Illinois, USA
            Article
            10.14293/S2199-rexpo22001.v1
            46c101fc-291a-466a-ac2e-7ea91d001025
            The Authors

            Published under Creative Commons Attribution 4.0 International ( CC BY 4.0). Users are allowed to share (copy and redistribute the material in any medium or format) and adapt (remix, transform, and build upon the material for any purpose, even commercially), as long as the authors and the publisher are explicitly identified and properly acknowledged as the original source.

            RExPO22
            Maastricht, Netherlands
            2-3 September, 2022
            History

            The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
            FDA,Clinical trial,Off-label pharmaceuticals,Drug repurposing

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